ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury

NCT07147296 | Recruiting DMC FDA Device

• 1 other identifier: ONWD-IM-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 11

Brief Summary

Empower BP is a pivotal, interventional, multicenter, prospective, randomized, controlled double-blinded study to evaluate the safety and effectiveness of the ARC-IM System in managing symptomatic blood pressure instability in individuals with chronic SCI (\>1 year after SCI). The primary effectiveness outcome will be evaluated through subject-reported ADFSCI and seated blood pressure assessments at 3 months post-implant. Following a baseline screening period and the surgical implantation of the ARC-IM System, subjects will be randomized with a 2:1 ratio into an active or control arm for 3 months. All the subjects will undergo therapy activation sessions (into either Group 1: active intervention, or Group 2: intervention aimed to mimic the active intervention without the active component) within 21 days of the surgical implant and will then commence independent at-home use of ARC-IM Therapy. At the 3 Month timepoint, after all assessments are conducted, all subjects will transition to the open-label period in order to receive the active version of the ARC-IM System in an open-label fashion. All subjects will undergo therapy programming sessions following Month 3.

Conditions

Spinal Cord Injuries; Blood Pressure Disorders

Outcome Measures

Primary Outcomes (3)

• Proportion of subjects achieving a change in the hypotension domain of the ADFSCI short-form questionnaire

  Proportion of subjects achieving a reduction of ≥ 4 points in the hypotension domain of the ADFSCI short-form questionnaire compared to baseline

  3-months post-implant

• Proportion of subjects achieving elevation in SBP during seated BP test

  Proportion of subjects achieving an elevation of ≥ 10 mmHg in systolic blood pressure during the seated BP test with stimulation ON compared to stimulation OFF

  3-months post-implant

• Incidence of serious adverse device effects

  Description of all Serious Adverse Device Effects from ARC-IM System implant until Month 6

  6-months post-implant

Study Arms (2)

Group 1

EXPERIMENTAL

ARC-IM System with active stimulation since day 0

Procedure: ARC-IM System Implantation; Device: ARC-IM Therapy (Group 1)

Group 2

SHAM COMPARATOR

ARC-IM System without active stimulation before the open-label phase of the study

Procedure: ARC-IM System Implantation; Device: ARC-IM Therapy (Group 2)

Interventions

ARC-IM System Implantation PROCEDURE

Implantation of the ARC-IM Thoracic Lead in the epidural space and ARC-IM Neurostimulator

Group 1; Group 2

ARC-IM Therapy (Group 1) DEVICE

The ARC-IM System is programmed since day 0 to deliver active electrical spinal cord stimulation at the low thoracic level for the management of symptomatic blood pressure instability in people with chronic spinal cord injury

Group 1

ARC-IM Therapy (Group 2) DEVICE

The ARC-IM System is programmed at month 3 to deliver active electrical spinal cord stimulation at the low thoracic level for the management of symptomatic blood pressure instability in people with chronic spinal cord injury

Group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or above, and no older than 75 years at the time of enrollment.
• Clinical evidence of Orthostatic Hypotension (blood pressure drop of 20mmHg systolic or 10mmHg diastolic) measured during Head Up Tilt Table assessment (HUTT, within 10 minutes) with current standard of care if any. 2 out of 3 tests must meet OH criteria.
• Clinical evidence of sustained hypotension (average systolic Blood pressure ≤ 110 mmHg) when measured each minute for 10 minutes while seated and in the absence of supportive compressive garments and medication.
• Evidence of symptomatic hypotension as determined by a non-zero OHSA total score
• A Spinal cord injury at the neurologic level between C2 and T6 inclusive.
• American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification A, B, C, or D.
• Traumatic (non-progressive) chronic spinal cord injury with minimum 12 months post-injury prior to study entry.
• Average A-P diameter of the sponal canal ≥ 13 mm, measured on MRI at the disc space at level(s) planned for implantation
• Stable medical, physical, and psychological condition as considered by the investigators.
• Stable dose of blood pressure medication for 30-days prior to enrollment into the study . Stability will be defined as no changes to medication regimens based on treating physician instructions.
• Subjects who are on long-term antihypertensive treatment must discontinue these medications no less than 30 days prior to enrollment in the study. This requirement does not apply to antihypertensive agents administered for the acute management of autonomic dysreflexia (AD)
• If the subject requires daily continuous support from a personal caregiver, the presence of a caregiver during the study visits is mandatory.
• Willing and able to provide informed consent.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Willing and able to comply with the instructions for use, operate the study devices, and comply with this clinical investigation plan

You may not qualify if:

• Subject has an autoimmune etiology of spinal cord dysfunction/injury.
• Subject has diseases and conditions that would increase the morbidity and mortality of the surgical procedures required by the study.
• Subject has a history of physiologic hypotension prior to SCI
• Subject has a history of unexpected blood pressure instability related to medications
• Inability to withhold antiplatelet/anticoagulation agents perioperatively.
• History of myocardial infarction or cerebrovascular event within the past 6 months. or
• History of chronic/recurrent severe cardiac arrythmias (e.g., ventricular tachycardia, ventricular fibrillation, third degree atrioventricular block)
• Evidence of clinically significant underlying cardiac conditions on Holter monitoring performed at screening including but not limited to arrhythmias (e.g., atrial fibrillation, ventricular tachycardia),
• Evidence of ischemic changes or prolonged QT interval (QTc \> of 450 ms for males and 470 ms for females) identified on EKG during screening,
• Subjects with a known diagnosis of heart failure, including but not limited to New York Heart Association (NYHA) Class I-IV, or with evidence of clinically significant left ventricular dysfunction (ejection fraction \< 40%) as determined by echocardiogram during screening or within the past 6 months,
• Current renal/kidney, hepatic, or other concomitant disorders deemed severe by the Investigator including those ones that could be linked to severe autonomic dysreflexia.
• Requires continuous ventilator support.
• Imaging (MRI, CT, X-ray) findings within the last 12 months that contraindicate lead placement
• Known allergic reaction to implanted materials
• Requires continuous/frequent/any transcutaneous spinal cord stimulation treatment.

Sponsors & Collaborators

• ONWARD Medical, Inc.: lead

Study Sites (11)

University of Arkansas for medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Craig Hospital

Englewood, Colorado, 80113, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Shepherd Center / Emory University

Atlanta, Georgia, 30309, United States

RECRUITING

UofL Health - Frazier Rehabilitation Institute

Louisville, Kentucky, 40202, United States

RECRUITING

VA Louisville

Louisville, Kentucky, 40245, United States

RECRUITING

Kennedy krieger Institute

Baltimore, Maryland, 21205, United States

RECRUITING

Spaulding Rehabilitation

Cambridge, Massachusetts, 02138, United States

RECRUITING

Mayo clinic

Rochester, Minnesota, 55905, United States

RECRUITING

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, controlled study consisting of a 3-month double-blinded phase followed by a 21-month open-label phase

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 29, 2025
• Study Start: October 17, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)